Overview of Program:

This program aims to establish a more predictable pathway for use of external evidence methods (EEM), such as new, innovative (Frequentist/Bayesian) methods and the cataloging of existing methods for evidence fusion from data external to a clinical trial.  External trial data includes but is not limited to real-world data (RWD), real-world evidence (RWE), engineering modeling and simulation, similar device clinical trial data, to support regulatory medical device decisions and other stakeholder decisions.